boceprevir treatment in participants with chronic hepatitis c genotype 1 deemed nonresponders to peginterferon/ribavirin (p05514)

Conditions: Hepatitis C, Chronic

Summary: this is a single-arm, multicenter study of boceprevir (boc) in combination with peginterferon plus ribavirin (peg/rbv) in adult chronic hepatitis c (chc) genotype 1 participants who completed their per-protocol defined treatment and did not achieve sustained viral response (svr) while in the peg/rbv control arm(s) of an schering-plough research institute (spri) study of boc combination therapy. participants who are able to enroll in this study within 2 weeks after the last dose of peg/rbv in previous protocol are to receive boc+ peg/rbv for up to 44 weeks followed by 24 weeks post-treatment follow-up. participants who are not able to enroll in this study within 2 weeks after the last dose of peg/rbv in previous protocol are to receive peg/rbv for 4 weeks followed by boc+ peg/rbv for up to 44 weeks, with 24 weeks post-treatment follow-up.


Eligibility criteria:
inclusion criteria: * participant must have been assigned to a peg/rbv control arm in a previous spri study of boc, must have completed treatment as per protocol, and have been compliant with all study treatment and scheduled procedures within the previous study. * participant must have received at least 12 weeks of treatment with peg/rbv and must have discontinued treatment in the previous study due to the futility rule (as defined in the previous protocol), had virologic breakthrough, or relapse. * participant must have had detectable hcv-rna upon completion of the previous study. * participant and participant partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs, or longer if dictated by local regulations. * participant must be willing to give written informed consent. exclusion criteria: * all participant exclusion criteria from the spri clinical study in which the participant participated prior to qualifying for this study will apply in this study, except for the following: * treatment with rbv within 90 days and any interferon-alpha within 1 month of the enrollment is not exclusionary in p05514. * participation in any other spri clinical trial within 30 days of enrollment in this study is not exclusionary. * use of growth factor at the entry of the study is allowed if it was prescribed in the previous study. * laboratory criteria of thyroid-stimulating hormone (tsh) do not apply. laboratory criteria of hemoglobin, neutrophils, and platelets do not apply, unless they met dose reduction/interruption/discontinuation criteria in the previous study. * participants who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded * participants who had the opportunity to receive boceprevir in the previous study. * participants requiring discontinuation, interruption, or dose reduction of rbv for more than 2 weeks in the previous study. * participants requiring discontinuation, interruption, or dose reduction of peg to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study. * participants who experienced a life-threatening sae considered at least possibly related to study drugs by the investigator or sponsor in the previous study.